| CTRI Number |
CTRI/2025/10/096179 [Registered on: 17/10/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study on the Impact of Vitamin C and E on Diabetes Control in Adults. |
|
Scientific Title of Study
|
Impact of Vitamin C and E Supplementation on Glycemic Control in Adults with Type 2 Diabetes Mellitus Receiving Standard Treatment: A Randomized Controlled Trial. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aneesh Basheer |
| Designation |
Professor, General Medicine |
| Affiliation |
SRMMCHRC, SRMIST |
| Address |
Department of general medicine,
SRMMCHRC,Kattankulathur, Chennai 603203
SRMMCHRC, Kattankulathur, chennai 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
919677154338 |
| Fax |
|
| Email |
aneeshb@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. N. Sai Supra Siddhu |
| Designation |
Professor Department of Pharmacy Practice |
| Affiliation |
SRM College of Pharmacy, SRMIST |
| Address |
SRM College of Pharmacy, SRMIST, Kattankulathur, Chengalpattu, Tamil Nadu-603203,India.
SRMMCHRC, Kattankulathur, chennai 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8500768402 |
| Fax |
|
| Email |
Nandimak1@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Infant Nikitha R |
| Designation |
Student investigator |
| Affiliation |
SRMMCHRC, SRMIST |
| Address |
Department of Pharmacy Practice, SRMMCHRC, Kattankulathur, chennai 603203
Department of Pharmacy Practice, SRMMCHRC, Kattankulathur, chennai 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9342286402 |
| Fax |
|
| Email |
ir8302@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital And Research Centre, SRM Institute of Science and Technology, Kattankulathur 603203, Chengalpattu District, Tamil Nadu,India. |
|
|
Primary Sponsor
|
| Name |
SRM Medical College Hospital And Research Centre Kattankulathur |
| Address |
SRM Medical College Hospital And Research Centre, SRM Institute of Science and Technology, Kattankulathur 603203, Chengalpattu District, Tamil Nadu,India. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mariyam Susan Joji |
SRM Medical College Hospital And Research Centre, Kattankalathur |
Department of General Medicine, SRM Medical College Hospital And Research Centre, SRM Institute of Science and Technology, Kattankulathur 603203, Chengalpattu District, Tamil Nadu,India.
Kancheepuram
TAMIL NADU |
7824838492
mj6873@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Treatment |
Standard medication of T2DM. |
| Intervention |
Supplement |
Oral intake of Vitamin C and E tablets by T2DM patients. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
T2DM patients receiving standard antidiabetic medication.
Willing and able to provide informed consent.
|
|
| ExclusionCriteria |
| Details |
Type 1 Diabetes Mellitus patients.
Diabetic complications, such as: retinopathy, nephropathy, neuropathy, ketoacidosis, or hyperosmolar state
Pregnant or lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the change in glycemic control and insulin resistance from baseline to 12 weeks |
Baseline (week 0), Weeks 4,8 and 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the adverse effects and tolerability of vitamin C and E supplementation in type 2 diabetic patients.
To assess the effect of vitamin C and E supplementation on blood pressure in type 2 diabetic patients.
|
Baseline (week 0), Weeks 4,8 and 12 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study investigates whether supplementing standard treatment with vitamins C and E can improve glycemic control in adults with type 2 diabetes mellitus (T2DM). It uses a 12-week, randomized clinical trial design with participants divided into two groups: one receiving vitamins C and E alongside standard therapy (e.g., metformin) and the other receiving standard therapy alone.
The primary goal is to assess improvements in glycemic parameters, while secondary goals include evaluating insulin sensitivity and overall health. The study aims to identify the potential benefits of antioxidant supplementation as an adjunct to standard diabetes treatment, with the ultimate goal of informing strategies to reduce complications and improve outcomes in adults with T2DM. |